Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020766
Company: CHEPLAPHARM
Company: CHEPLAPHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| XENICAL | ORLISTAT | 120MG | CAPSULE;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/23/1999 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20766lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20766ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020766a.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/17/2022 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020766s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020766Orig1s038ltr.pdf | |
| 08/12/2016 | SUPPL-36 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020766Orig1s036ltr.pdf |
| 08/07/2015 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020766s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020766Orig1s035ltr.pdf | |
| 04/30/2014 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/16/2013 | SUPPL-33 | Labeling, Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020766s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020766Orig1s033ltr.pdf | |
| 04/02/2013 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/2013 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/2010 | SUPPL-30 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020766s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020766s030ltr.pdf | |
| 01/20/2012 | SUPPL-29 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020766s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020766s029ltr.pdf | |
| 05/25/2010 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020766s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020766s028ltr.pdf | |
| 02/11/2009 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020766s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020766s026ltr.pdf | |
| 01/05/2007 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020766s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020766s022_ltr.pdf | |
| 09/02/2005 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020766s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020766s021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020766_S021_XENICAL_CAPS_AP.pdf | |
| 07/09/2004 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20766slr020_xenical_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20766slr020ltr.pdf | |
| 10/22/2004 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20766s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20766s019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020766_S019_XENICAL_CAPS_AP.pdf | |
| 12/12/2003 | SUPPL-18 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20766se5-018_xenical_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20766se5-018ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020766_S018_XENICAL_CAPSULES_AP.pdf | |
| 02/27/2002 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/08/2002 | SUPPL-13 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020766_S013_XENICAL_CAPS_AP.pdf |
| 02/21/2002 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/19/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/19/2001 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/12/2001 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020766_S009_XENICAL_CAPS_AP.pdf |
| 06/25/2001 | SUPPL-7 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20766s7lbl.pdf | |
| 01/29/2001 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/09/2001 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/06/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 04/06/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/31/1999 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/17/2022 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020766s038lbl.pdf | |
| 08/07/2015 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020766s035lbl.pdf | |
| 10/16/2013 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020766s033lbl.pdf | |
| 10/16/2013 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020766s033lbl.pdf | |
| 10/16/2013 | SUPPL-33 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020766s033lbl.pdf | |
| 01/20/2012 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020766s029lbl.pdf | |
| 01/20/2012 | SUPPL-29 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020766s029lbl.pdf | |
| 12/17/2010 | SUPPL-30 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020766s030lbl.pdf |
| 05/25/2010 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020766s028lbl.pdf | |
| 02/11/2009 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020766s026lbl.pdf | |
| 01/05/2007 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020766s022lbl.pdf | |
| 09/02/2005 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020766s021lbl.pdf | |
| 10/22/2004 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20766s019lbl.pdf | |
| 07/09/2004 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20766slr020_xenical_lbl.pdf | |
| 12/12/2003 | SUPPL-18 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20766se5-018_xenical_lbl.pdf | |
| 06/25/2001 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20766s7lbl.pdf | |
| 04/23/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20766lbl.pdf |